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Abbott Receives FDA Approval for HUMIRA(R) (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

Saturday, February 23, 2008 General News J E 4
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ABBOTT PARK, Ill., Feb. 22 Abbott (NYSE: ABT)announced today it has received U.S. Food and Drug Administration (FDA)approval to market HUMIRA(R) (adalimumab) as a treatment to reduce signs andsymptoms of moderately to severely active polyarticular juvenile idiopathicarthritis (JIA) in patients four years of age and older. In the U.S., JIA iscommonly referred to as juvenile rheumatoid arthritis (JRA). The approval isbased on safety and efficacy results from a clinical study of JIA patientsfour to 17 years of age. HUMIRA is the first biologic treatment to receiveFDA approval for this condition since 1999, and the first to be administeredby injection in these patients once every two weeks.

"The pain and inflammation caused by JIA can be debilitating for somechildren, making it hard for them to run, jump, play or participate in otheractivities with children their age," said Daniel J. Lovell, M.D., M.P.H.,associate director, Division of Rheumatology, Cincinnati Children's HospitalMedical Center, Cincinnati. "HUMIRA is an important new treatment that givesphysicians and families another option that can ease the symptoms ofpolyarticular JIA."

JIA is the most common chronic rheumatic disease in children with onsetbefore age 16. Typical symptoms include stiffness when awakening, limping,and joint swelling. Any joint can be affected and inflammation may limit themobility of the affected joints. While it was once believed that mostchildren eventually outgrow JIA, it is now known that between 25 and 70percent of children with JIA will still have active disease into adulthood.

"The symptoms of JIA can make it difficult for children to experience manyof the simple joys of childhood," said John Hardin, M.D., chief scientificofficer, Arthritis Foundation. "The Arthritis Foundation welcomes theapproval of new therapies that expand effective treatment options for doctorsand families, helping children and adolescents to keep their symptoms undercontrol."

JIA is the sixth disease indication for which HUMIRA has received approvalsince 2002.

HUMIRA JIA Clinical Study

The approval is based on the results of a 48-week study and a subsequentopen-label extension evaluating the efficacy and safety of HUMIRA. In the48-week study, fewer children treated with HUMIRA experienced disease flarecompared to placebo. Overall, children on HUMIRA experienced improvements intheir disease symptoms.

The 48-week Phase III study included 171 children (four to 17 years ofage) with polyarticular JIA, a form of arthritis affecting five or morejoints, usually the same joints on both sides of the body.

In the first part of this study, two groups of patients -- those takingmethotrexate (MTX) and those not taking MTX -- received open-label HUMIRA (upto a maximum of 40 mg) every other week for 16 weeks. Patient responses weremeasured using the American College of Rheumatology Pediatric (ACR Pedi) 30score, which represents a 30 percent or greater improvement in JIA signs andsymptoms, such as the number of swollen joints with loss of motion, assessmentof pain and level of disability. Children who showed a positive clinicalresponse (n=133) entered the second part of the study and were randomized toreceive HUMIRA or placebo for an additional 32 weeks or until disease flare.A flare was defined as a worsening of 30 percent or more in at least three ofthe six ACR Pedi response variables, a minimum of two active joints, and nomore than one indicator improving by 30 percent.

In the second part of this study, significantly fewer children receivingHUMIRA demonstrated disease flare compared to children on placebo, bothwithout MTX (43 percent vs. 71 percent) and with MTX (37 percent vs. 65percent). Additionally, more patients treated with HUMIRA continued to showACR Pedi 30/50/70 responses at week 48 compared to placebo.

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